Back to resultsPhysical Activity in Overweight Girls: Implications for Reversing Risk Factors for Type 2 Diabetes
Primary Purpose
Abdominal Obesity, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Resistance Exercise
Aerobic exercise
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Obesity focused on measuring Childhood obesity, Visceral fat, Insulin resistance, Liver fat, Skeletal muscle lipid, Regular exercise
Eligibility Criteria
Inclusion Criteria:
- Healthy overweight (BMI >-95th) youth between 12 and 18 years of age
- Waist circumference >-75th percentile
- Sedentary (no structured exercise >2 times/week for past 6 months)
- Non-smokers, non-diabetic, no medical conditions
- Weight stable for past 3 months
Exclusion Criteria:
- Smokers
- Diabetes
- Psychiatric disorders
- Syndromic obesity
- Pregnancy
- Taking medications known to affect study outcomes
Sites / Locations
- Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Active Comparator
Active Comparator
Arm Label
Control
Aerobic Exercise
Resistance Exercise
Arm Description
Standard care control (no-exercise)
Outcomes
Primary Outcome Measures
Abdominal obesity, visceral fat
Secondary Outcome Measures
insulin sensitivity by a 3-hour hyperinsulinemic-euglycemic clamp, oral glucose tolerance test, liver fat and intramyocellular lipid by 1H-magnetic resonance spectroscopy.
Full Information
NCT ID
NCT01323088
First Posted
March 22, 2011
Last Updated
April 12, 2013
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT01323088
Brief Title
Physical Activity in Overweight Girls: Implications for Reversing Risk Factors for Type 2 Diabetes
Official Title
Physical Activity in Overweight Girls: Implications for Reversing Risk Factors for Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this randomized controlled trial, we will examine the effect of a 3-month exercise training (aerobic exercise versus resistance exercise) without calorie restriction on total and regional adiposity, ectopic fat in the liver and skeletal muscle, and risk of type 2 diabetes in overweight girls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity, Physical Activity
Keywords
Childhood obesity, Visceral fat, Insulin resistance, Liver fat, Skeletal muscle lipid, Regular exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Description
Standard care control (no-exercise)
Arm Title
Aerobic Exercise
Arm Type
Active Comparator
Arm Title
Resistance Exercise
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Standard care control (no exercise)
Intervention Type
Other
Intervention Name(s)
Resistance Exercise
Intervention Description
Supervised resistance exercise using stack weight equipments.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
Supervised aerobic exercise using treadmills, bikes, and ellipticals
Primary Outcome Measure Information:
Title
Abdominal obesity, visceral fat
Time Frame
3 month
Secondary Outcome Measure Information:
Title
insulin sensitivity by a 3-hour hyperinsulinemic-euglycemic clamp, oral glucose tolerance test, liver fat and intramyocellular lipid by 1H-magnetic resonance spectroscopy.
Time Frame
3 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy overweight (BMI >-95th) youth between 12 and 18 years of age
Waist circumference >-75th percentile
Sedentary (no structured exercise >2 times/week for past 6 months)
Non-smokers, non-diabetic, no medical conditions
Weight stable for past 3 months
Exclusion Criteria:
Smokers
Diabetes
Psychiatric disorders
Syndromic obesity
Pregnancy
Taking medications known to affect study outcomes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SoJung Lee, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33739874
Citation
Yu WW, Lee S, Arslanian S, Tamim H, Kuk JL. Effects of Exercise on Resting Metabolic Rate in Adolescents with Overweight and Obesity. Child Obes. 2021 Jun;17(4):249-256. doi: 10.1089/chi.2020.0280. Epub 2021 Mar 18.
Results Reference
derived
PubMed Identifier
32674604
Citation
Kuk JL, Lee S. Assessing the utility of cardiorespiratory fitness, visceral fat, and liver fat in predicting changes in insulin sensitivity beyond simple changes in body weight after exercise training in adolescents. Appl Physiol Nutr Metab. 2021 Jan;46(1):55-62. doi: 10.1139/apnm-2020-0284. Epub 2020 Jul 16.
Results Reference
derived
PubMed Identifier
31235380
Citation
Kuk JL, Lee S. Sex and Ethnic Differences in the Relationship between Changes in Anthropometric Measurements and Visceral Fat in Adolescents with Obesity. J Pediatr. 2019 Oct;213:121-127. doi: 10.1016/j.jpeds.2019.05.052. Epub 2019 Jun 22.
Results Reference
derived
Learn more about this trial
Physical Activity in Overweight Girls: Implications for Reversing Risk Factors for Type 2 Diabetes
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